Frenda Corporation — FDA Warning Letter Findings

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Quality System Your firm failed to establish an adequate Quality Unit (QU) with the responsibilities and authority to oversee the manufacture of your drug products. For example, you failed to ensure: Adequate procedures describing roles and…

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Component Testing You failed to conduct an identity test on each shipment of each lot of components used in the production of your drug products…

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). Your equipment in your facility was observed in a state of disrepair. For example, our investigators observed the appearance of rust-like residues on the surfaces of the filling equipment and the presence of dirty and damaged seals on the filling line injector nozzles that contact the product. In addition, you did not maintain written cleaning procedures or equipment use logs for Filling Line (b)(4) used to manufacture drug product and non-pharmaceutical industrial chemicals. It is your responsibility to ensure that only appropriately designed and maintained equipment are used in the manufacture of your drug products.

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)). You failed to adequately design, validate, and control your water system to ensure that it was suitable for producing water used in the formulation of your drug products. For example, you lacked water system validation, chemical and microbiological limits for component water, and routine monitoring for chemical and microbiological quality. Inadequate control and monitoring of your water system pose a potential risk for the presence of objectionable microbiological contamination in your drug products. Pharmaceutical water must meet the Purified Water USP monograph, be suitable for its intended use, and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.